MAQUET HL-20 System - The STI 1/2" x 1/16" (4 pcs) is a Single Tube - Maquet Cardiopulmonary AG

Duns Number:316153865

Device Description: The STI 1/2" x 1/16" (4 pcs) is a Single Tube Insert RPM, RPM 20-230 functions as an acces The STI 1/2" x 1/16" (4 pcs) is a Single Tube Insert RPM, RPM 20-230 functions as an accessroy for The Heart-Lung Machine HL 20, which is a modular system to drive, control and Monitor extracorporeal circulation. A heart lung machine is used in different surgical and non-surgical specialties. Cardiac surgical procedures requiring cardiopulmonary bypass comprise the vast majority of applications. However, there are some very special procedures that may require a heart-lung machine for extracorporeal bypass support. During these procedures the HL 20 adopts the blood pumping function of the heart while a disposable oxygenator takes over the gas exchange functionalities of the lung.

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More Product Details

Catalog Number

701020800

Brand Name

MAQUET HL-20 System

Version/Model Number

STI 1/2" x 1/16" (4 pcs)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K943803

Product Code Details

Product Code

DTQ

Product Code Name

Console, Heart-Lung Machine, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

4e377577-e0de-4ca3-a194-17c1703ba802

Public Version Date

October 01, 2021

Public Version Number

4

DI Record Publish Date

September 18, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MAQUET CARDIOPULMONARY AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 286